SyneuRx Reaches Target Enrollment in Phase 2 Clinical Trial of COVID-19 Oral Antiviral Candidate Pentarlandir� (SNB01)

Early research suggests Pentarlandir is safe to use against COVID-19; Phase 3 trial evaluating effectiveness against both COVID-19 and influenza is expected in the coming months

LOS ANGELES & NEW TAIPEI CITY, Taiwan–(BUSINESS WIRE)–SyneuRx� International (TPEX:6575), a global biotech company focused on the development of new classes of drugs for COVID-19 and multiple major central nervous system disorders, today announced it has completed enrollment for its phase 2 clinical trial evaluating the efficacy and safety of SNB01 (‘Pentarlandir’), a novel COVID-19 oral antiviral candidate. In preclinical studies, Pentarlandir demonstrated preliminary efficacy and an excellent safety profile against Omicron, Delta, and previously identified variants of concern in addition to several influenza viruses.

“COVID-19 continues to plague many parts of the world, including individuals who are immunocompromised, unvaccinated or not up to date on vaccines, or who experience breakthrough infection even when vaccinations are up to date,” said Emil Tsai, M.D.-Ph.D., M.A.S., founder and CEO of SyneuRx. “Antivirals that can potentially address multiple variants are much-needed, new tools to combat COVID-19 at a crucial time as new outbreaks continue to emerge.”

In the phase 2 study, 89 participants suffering from unvaccinated or early-stage breakthrough cases of COVID-19 were randomized evenly into high-dose, low-dose, and placebo groups. For the phase 3 study expected to begin in the coming months, an optimal dose will be selected and the scope will expand to evaluate Pentarlandir’s broad-spectrum antiviral activity in inhibiting SARS-CoV-2 as well as influenza viruses, including rigorous safety assessments.

Tsai continued, “Our goal from the start has been to introduce a safe, effective and accessible therapeutic with multiple use cases, including the ability to work against most COVID-19 variants and treat certain influenza strains in order to keep high-risk patients from hospitalization due to the potential ‘twindemic’ caused by COVID-19 and/or influenza.”

To learn more about the Pentarlandir phase 2 clinical trial, visit clinicaltrials.gov (NCT Number: NCT04911777).

To learn more about SyneuRx, visit syneurx.com.

About Pentarlandir

Working through years of research into how several debilitating central nervous system diseases operate, SyneuRx scientists arrived at the theory that regulatory enzymes such as protease would be a critically-important ‘drug target’ for these types of illnesses, which coincidentally is also a target for several virally-caused diseases such as HIV and hepatitis. Researchers decided to test all of the compounds in the company’s patent portfolio against protease and discovered that several SyneuRx-developed compounds were potent protease blockers, of which the compound that became Pentarlandir proved to be the most safe and efficacious in preclinical tests. SyneuRx confirmed its ability to block coronavirus replication in multiple, rigorous cellular studies and it also proved to maintain an excellent safety profile, which made Pentarlandir an ideal candidate to go into clinical development. SyneuRx has found Pentarlandir also may block replication of several influenza viruses in cellular assay. The company continues to test the efficacy of Pentarlandir against other potentially lethal viral strains.

About SyneuRx

SyneuRx International (TPEX:6575) is a clinical-stage global biotech company focused on the development of new classes of drugs for COVID-19 and multiple major central nervous system (CNS) disease conditions. Founded in 2013, SyneuRx is poised to bring change-making pharmaceuticals to market with a robust, promising pipeline of seven investigational drugs for CNS disorders and two for COVID-19 – eight of which are currently in phase 2 and phase 3 clinical trials with the U.S. Food and Drug Administration. The company’s mission is to infuse a scientific and humanistic approach into its research and development of safe, effective, and accessible therapies for patients suffering from disorders such as schizophrenia, dementia, depression, as well as COVID-19 and other RNA-encoded viruses. Dedicated to taking a safety-first approach with its research and development by focusing on well-established lead compounds as well as natural sources and plant substances to treat or prevent illness, SyneuRx has received Breakthrough Therapy Designations and Orphan Drug Designations from the FDA for two of its novel CNS therapeutics. To learn more, visit syneurx.com.

Disclosure Notice

The information contained in this release is as of April 13, 2022. SyneuRx assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about SyneuRx’s efforts to combat COVID-19 as well as flu and the company’s investigational oral antiviral candidate Pentarlandir® (including qualitative assessments of available data, potential benefits, expectations for clinical trials, advanced purchase agreements, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations, planned investment and anticipated manufacturing, distribution and supply), involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results including efficacy, safety and tolerability profile observed to date, in additional studies or in larger, more diverse populations following commercialization; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any drug applications or submissions to request emergency use or conditional marketing authorization for any potential indications for Pentarlandir may be filed in any jurisdictions and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when regulatory authorities in any jurisdictions may approve any such applications for Pentarlandir, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pentarlandir, including development of products or therapies by other companies; risks related to the availability of raw materials for Pentarlandir; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand, which would negatively impact our ability to supply the estimated numbers of courses of Pentarlandir within the projected time periods; whether and when additional purchase agreements will be reached; the risk that demand for any products may be reduced or no longer exist; uncertainties regarding the impact of COVID-19 on SyneuRx’s business, operations and financial results; and competitive developments.

Contacts

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